Surgical stents have long been known which can be surgically implanted into a body lumen, such as an artery, to reinforce, support, repair or otherwise enhance the performance of the lumen. For instance, in cardiovascular surgery it is often desirable to place a stent in the coronary artery at a location where the artery is damaged or is susceptible to collapse. The stent, once in place, reinforces that portion of the artery allowing normal blood flow to occur through the artery. One form of stent which is particularly desirable for implantation in arteries and other body lumens is a cylindrical stent which can be radially expanded from a first smaller diameter to a second larger diameter. Such radially expandable stents can be inserted into the artery by being located on a catheter and fed internally through the arterial pathways of the patient until the unexpanded stent is located where desired. The catheter is fitted with a balloon or other expansion mechanism which exerts a radial pressure outward on the stent causing the stent to expand radially to a larger diameter. Such expandable stents exhibit sufficient rigidity after being expanded that they will remain expanded after the catheter has been removed.
Radially expandable stents come in a variety of different configurations to provide optimal performance to various different particular circumstances. For instance, the patents to Lau (U.S. Pat. Nos. 5,514,154, 5,421,955, and 5,242,399), Baracci (U.S. Pat. No. 5,531,741), Gaterud (U.S. Pat. No. 5,522,882), Gianturco (U.S. Pat. Nos. 5,507,771 and 5,314,444), Termin (U.S. Pat. No. 5,496,277), Lane (U.S. Pat. No. 5,494,029), Maeda (U.S. Pat. No. 5,507,767), Marin (U.S. Pat. No. 5,443,477), Khosravi (U.S. Pat. No. 5,441,515), Jessen (U.S. Pat. No. 5,425,739), Hickle (U.S. Pat. No. 5,139,480), Schatz (U.S. Pat. No. 5,195,984), Fordenbacher (U.S. Pat. No. 5,549,662) and Wiktor (U.S. Pat. No. 5,133,732), each include some form of radially expandable stent for implantation into a body lumen.
Each of these prior art stents suffer from a variety of drawbacks which make them less than ideal. For instance, many of these stents are formed from stainless steel or other materials which have a relatively low yield strength. Hence, if the body lumen is subjected to radial loads and related radial stresses, the stents are susceptible to collapse or other permanent deformation in an undesirable manner. If such stents are provided with segments of greater thickness to enhance their strength, they become too thick to be effectively collapsed for insertion and later expansion within the body lumen.
One material for forming higher strength radially expandable surgical stents is a shape memory Nickel-Titanium alloy. Shape memory Nickel-Titanium alloys and other shape memory alloys are unique in that they have two distinct solid phases. A high yield strength austenite phase (195-690 MPa) and a lower yield strength martensite phase (70-140 MPa). The material can be selectively transformed between the austenite phase and the martensite phase by altering a temperature of the shape memory Nickel-Titanium alloy. For instance, it is known to form the Nickel-Titanium alloy so that the stent is in the martensite phase when chilled to a temperature below body temperature and to be in the austenite phase when the stent is at body temperature.
Additionally, when such shape memory alloys are stressed beyond their yield strength while in the martensite phase, not to exceed certain maximum amounts of strain, the alloy has a"memory" of its shape before its yield strength in the martensite phase was exceeded so that when the alloy is heated and transformed into its austenite phase it returns to the shape it exhibited before it was plastically deformed in the martensite phase. In radially expandable surgical stents, this shape memory has been used to collapse the stent to a small diameter when in its martensite phase and then heat the stent up to body temperature and transform the stent into its austenite phase where it radially expands back to its original expanded diameter and exhibits a desired strength and size for supporting walls of the body lumen in which it is implanted. Hence, the relatively high yield strength of the shape memory alloy stent in its austenite phase provides beneficial characteristics for supporting the body lumen while the martensite phase for the shape memory alloy stent is utilized to allow the stent to be easily radially contracted and deformed during implantation of the stent.
While such shape memory Nickel-Titanium alloy stents are generally effective, known shape memory Nickel-Titanium stents have exhibited certain deficiencies. For instance, when such prior art shape memory Nickel-Titanium stents are radially expanded they tend to contract axially, enhancing the difficulty experienced by a surgeon in precisely implanting the stent where desired. Additionally, the limited degree of collapsibility of known prior art shape memory Nickel-Titanium stents has enhanced the difficulty of their implantation in many body lumens. Accordingly, a need exists for shape memory Nickel-Titanium alloy stents which have a configuration which beneficially overcomes the drawbacks of known prior art shape memory Nickel-Titanium alloy stents.